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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Heating (1287)
Patient Problems Seizures (2063); No Code Available (3191); Convulsion/Seizure (4406)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the infant patient was still not at target temperature on the arctic sun device. Patient should have completed rewarm 2 hours ago but neonatal arctic gel pads were in use. The patient temperature was 35c, the target temperature was 36. 5c and the water temperature was 40c. Trend indicator was in thermoneutral. Concerned and wants to ensure the arctic sun device was working properly. The user has not had an infant unable to rewarm before. Discussed medications being given to patient was keppra, fentanyl, dopamine and versed drip. The user usually does not order versed drip, but it has been the medication able to control patient seizures. Discussed medication affects on rewarming. Discussed counter warming with radiant warmer set to target temperature and watching patient to ensure overshoot does not occur. Also noted blankets could be used to assist with counter warming. Going to try radiant warmer and would call back with any additional questions. Per follow up via nurse on (b)(6) 2020, the nurse had added a radiant warmer and increased the room temperature. The nurse denied a administering versed and was unsure which arctics sun device the infant had been on as patient was completed last week and the arctic sun device has since been moved around. No further issues. The arctic sun device was still in service.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key10741457
MDR Text Key213236629
Report Number1018233-2020-20463
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000-BARD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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